Hepatitis B vaccine

Last updated

Hepatitis B vaccine
Engerix B (Hepatitis B) vaccine.jpg
Hepatitis B vaccine
Vaccine description
Target Hepatitis B virus
Vaccine type Subunit
Clinical data
Trade names Recombivax HB, Engerix-B, Heplisav-B, others
AHFS/Drugs.com Monograph
MedlinePlus a607014
License data
Pregnancy
category
Routes of
administration
Intramuscular (IM)
Drug class Antiviral
ATC code
Legal status
Legal status
Identifiers
PubChem CID
DrugBank
ChemSpider
  • none
UNII
KEGG
 X mark.svgNYes check.svgY  (what is this?)    (verify)

Hepatitis B vaccine is a vaccine that prevents hepatitis B. [13] The first dose is recommended within 24 hours of birth with either two or three more doses given after that. [13] This includes those with poor immune function such as from HIV/AIDS and those born premature. [13] It is also recommended that health-care workers be vaccinated. [14] In healthy people, routine immunization results in more than 95% of people being protected. [13]

Contents

Blood testing to verify that the vaccine has worked is recommended in those at high risk. [13] Additional doses may be needed in people with poor immune function but are not necessary for most people. [13] In those who have been exposed to the hepatitis B virus (HBV) but not immunized, hepatitis B immune globulin should be given in addition to the vaccine. [13] The vaccine is given by injection into a muscle. [13]

Serious side effects from the hepatitis B vaccine are very uncommon. [13] Pain may occur at the site of injection. [13] It is safe for use during pregnancy or while breastfeeding. [13] It has not been linked to Guillain–Barré syndrome. [13] Hepatitis B vaccines are produced with recombinant DNA techniques and contain immunologic adjuvant. [13] They are available both by themselves and in combination with other vaccines. [13]

The first hepatitis B vaccine was approved in the United States in 1981. [15] A recombinant version came to market in 1986. [13] It is on the World Health Organization's List of Essential Medicines. [16] [17] Both versions were developed by Maurice Hilleman and his team. [18] [19] [20]

Medical uses

In the United States vaccination is recommended for nearly all babies at birth. [21] Many countries routinely vaccinate infants against hepatitis B. In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to a marked reduction in liver cancer. This was reported in Taiwan where the implementation of a nationwide hepatitis B vaccination program in 1984 was associated with a decline in the incidence of childhood hepatocellular carcinoma. [22]

In the UK, the vaccine is offered to men who have sex with men (MSM), usually as part of a sexual health check-up. A similar situation is in operation in Ireland. [23]

In many areas, vaccination against hepatitis B is also required for all health-care and laboratory staff. [24] Both types of the vaccine, the plasma-derived vaccine (PDV) and recombinant vaccine (RV), seems to be able to elicit similar protective anti-HBs levels. [14]

The US Centers for Disease Control and Prevention (CDC) issued recommendations for vaccination against hepatitis B among patients with diabetes mellitus. [25] The World Health Organization (WHO) recommends a pentavalent vaccine, combining vaccines against diphtheria, tetanus, pertussis and Haemophilus influenzae type B with the vaccine against hepatitis B.[ medical citation needed ] There is not yet sufficient evidence on how effective this pentavalent vaccine is in relation to the individual vaccines. [26] A pentavalent vaccine combining vaccines against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis is approved in the U.S. and is recommended by the Advisory Committee on Immunization Practices (ACIP). [27] [28] [29]

Hepatitis B vaccination, hepatitis B immunoglobulin, and the combination of hepatitis B vaccine plus hepatitis B immunoglobulin, all are considered as preventive for babies born to mothers infected with hepatitis B virus (HBV). [30] The combination is superior for protecting these infants. [30] The effectiveness of being vaccinated during pregnancy to prevent vertical transmission of hepatitis B to infants has not been studied. [31] Hepatitis B immunoglobulin before birth has not been well studied. [32]

Effectiveness

Studies have found that that immune memory against HepB is sustained for at least 30 years after vaccination, and protects against clinical disease and chronic HepB infection, even in cases where anti-hepatitis B surface antigen (anti-Hbs) levels decline below detectable levels. [33] Testing to confirm successful immunization or sustained immunity is not necessary or recommended for most people, but is recommended for infants born to a mother who tests positive for HBsAg or whose HBsAg status is not known; for healthcare and public safety workers; for immunocompromised people such as haemodialysis patients, HIV patients, haematopoietic stem cell transplant [HSCT] recipients, or people receiving chemotherapy; and for sexual partners of HBsAg-positive people. [33]

An anti-Hbs antibody level above 100  mIU/ml is deemed adequate, and occurs in about 85–90% of individuals. [34] An antibody level between 10 and 100 mIU/ml is considered a poor response, and these people should receive a single booster vaccination at this time, but do not need further retesting. [34] People who fail to respond (anti-Hbs antibody level below 10 mIU/ml) should be tested to exclude current or past hepatitis B infection, and given a repeat course of three vaccinations, followed by further retesting 1–4 months after the second course. Those who still do not respond to a second course of vaccination may respond to intradermal injection [35] or to a high dose vaccine [36] or to a double dose of a combined hepatitis A and B vaccine. [37] Those who still fail to respond will require hepatitis B immunoglobulin (HBIG) if later exposed to the hepatitis B virus. [34]

Poor responses are mostly associated with being over the age of 40 years, obesity, celiac disease, and tobacco smoking, [35] [38] and also in alcoholics, especially if with advanced liver disease. [39] People who are immunosuppressed or on dialysis may not respond as well and require larger or more frequent doses of vaccine. [34] At least one study suggests that hepatitis B vaccination is less effective in patients with HIV. [40]

Duration of protection

Hepatitis B vaccine is now believed to provide indefinite protection. Older literature assumed that immunity would wane with antibody titers and only effectively last five to seven years, [41] [42] but immune-challenge studies show that even after 30 years, the immune system maintains the ability to produce an anamnestic response, i.e. to rapidly bump up antibody levels when the previously seen antigen is detected. [43] [44] This shows that the immunological memory is not affected by the loss of antibody levels. As a result, subsequent antibody testing and administration of booster doses is not required in successfully vaccinated immunocompetent individuals. [45] [46] UK guidelines suggest that people who respond to the vaccine and are at risk of occupational exposure, such as for healthcare workers, a single booster is recommended five years after initial immunization. [34]

Side effects

Serious side effects from the hepatitis B vaccine are very rare. [13] Pain may occur at the site of injection. [13] It is generally considered safe for use, during pregnancy or while breastfeeding. [13] [47] It has not been linked to Guillain–Barré syndrome. [13]

Multiple sclerosis

Several studies have looked for an association between recombinant hepatitis B vaccine and multiple sclerosis (MS) in adults. [48] Most studies do not support a causal relationship between hepatitis B vaccination and demyelinating diseases such as MS. [48] [49] [50] A 2004 study reported a significant increase in risk within three years of vaccination. Some of these studies were criticized for methodological problems. [51] This controversy created public misgivings about hepatitis B vaccination, and hepatitis B vaccination in children remained low in several countries. A 2006 study concluded that evidence did not support an association between hepatitis B vaccination and sudden infant death syndrome, chronic fatigue syndrome, or multiple sclerosis. [52] A 2007 study found that the vaccination does not seem to increase the risk of a first episode of MS in childhood. [53] Hepatitis B vaccination has not been linked to onset of autoimmune diseases in adulthood. [54]

Usage

Share of one-year-olds vaccinated against hepatitis B, 2017 Immunization-hepb3-of-one-year-old-children.png
Share of one-year-olds vaccinated against hepatitis B, 2017

The following is a list of countries by the percentage of infants receiving three doses of hepatitis B vaccine as published by the World Health Organization (WHO) in 2017. [56]

Hepatitis B (HepB3) immunization coverage
among one-year-olds worldwide
CountryCoverage %
Afghanistan65
Albania99
Algeria91
Andorra98
Angola52
Antigua and Barbuda95
Argentina86
Armenia94
Australia95
Austria90
Azerbaijan95
Bahamas94
Bahrain98
Bangladesh97
Barbados90
Belarus98
Belgium97
Belize88
Benin82
Bhutan98
Bolivia (Plurinational State of)83
Bosnia and Herzegovina77
Botswana95
Brazil93
Brunei Darussalam99
Bulgaria92
Burkina Faso91
Burundi91
Côte d'Ivoire84
Cabo Verde86
Cambodia93
Cameroon86
Canada69
Central African Republic47
Chad41
Chile93
China99
Colombia92
Comoros91
Congo69
Cook Islands99
Costa Rica97
Croatia94
Cuba99
Cyprus97
Czech Republic94
Democratic People's Republic of Korea97
Democratic Republic of the Congo81
Djibouti68
Dominica91
Dominican Republic81
Ecuador84
Egypt94
El Salvador85
Equatorial Guinea25
Eritrea95
Estonia92
Eswatini90
Ethiopia73
Fiji99
France90
Gabon75
Gambia92
Georgia91
Germany87
Ghana99
Greece96
Grenada96
Guatemala82
Guinea45
Guinea-Bissau87
Guyana97
Haiti58
Honduras97
India88
Indonesia79
Iran (Islamic Republic of)99
Iraq63
Ireland95
Israel97
Italy94
Jamaica93
Jordan99
Kazakhstan99
Kenya82
Kiribati90
Kuwait99
Kyrgyzstan92
Lao People's Democratic Republic85
Latvia98
Lebanon78
Lesotho93
Liberia86
Libya94
Lithuania94
Luxembourg94
Macedonia91
Madagascar74
Malawi88
Malaysia98
Maldives99
Mali66
Malta88
Marshall Islands82
Mauritania81
Mauritius96
Mexico93
Micronesia (Federated States of)80
Monaco99
Mongolia99
Montenegro73
Morocco99
Mozambique80
Myanmar89
Namibia88
Nauru87
Nepal90
Netherlands92
New Zealand94
Nicaragua98
Niger81
Nigeria42
Niue99
Oman99
Pakistan75
Palau98
Panama81
Papua New Guinea56
Paraguay91
Peru83
Philippines88
Poland95
Portugal98
Qatar97
Republic of Korea98
Republic of Moldova89
Romania92
Russian Federation97
Rwanda98
Saint Kitts and Nevis98
Saint Lucia80
Saint Vincent and the Grenadines99
Samoa73
San Marino86
São Tomé and Príncipe95
Saudi Arabia98
Senegal91
Serbia93
Seychelles98
Sierra Leone90
Singapore96
Slovakia96
Solomon Islands99
Somalia42
South Africa66
Spain93
Sri Lanka99
Sudan95
Suriname81
Swaziland98
Sweden76
Syrian Arab Republic52
Tajikistan96
Thailand99
Timor-Leste76
Togo90
Tonga81
Trinidad and Tobago89
Tunisia98
Turkey96
Turkmenistan99
Tuvalu96
Uganda85
Ukraine52
United Arab Emirates98
United Republic of Tanzania97
United States of America93
Uruguay95
Uzbekistan99
Vanuatu85
Venezuela (Bolivarian Republic of)84
Viet Nam94
Yemen68
Zambia94
Zimbabwe89

History

Preliminary work

In 1963, the American physician/geneticist Baruch Blumberg, working at the Fox Chase Cancer Center, discovered what he called the "Australia Antigen" (HBsAg) in the serum of an Australian Aboriginal person. [57] In 1968, this protein was found to be part of the virus that causes "serum hepatitis" (hepatitis B) by virologist Alfred Prince. [58]

In 1976, Blumberg won the Nobel Prize in Physiology or Medicine for his work on hepatitis B (sharing it with Daniel Carleton Gajdusek for his work on kuru). [59] Blumberg had identified Australia antigen, the important first step, and later discovered the way to make the first hepatitis B vaccine. Blumberg's vaccine was a unique approach to the production of a vaccine; that is, obtaining the immunizing antigen directly from the blood of human carriers of the virus. In October 1969, acting on behalf of the Institute for Cancer Research, they filed an application for a patent for the production of a vaccine. This patent [USP 3,636,191] was subsequently (January 1972) granted in the United States and other countries. In 2002, Blumberg published a book, Hepatitis B: The Hunt for a Killer Virus. [60] In the book, Blumberg wrote: “It took some time before the concept was accepted by virologists and vaccine manufacturers who were more accustomed to dealing with vaccines produced by attenuation of viruses, or the use of killed viruses produced in tissue culture, or related viruses that were non-pathogenic protective (i.e., smallpox). However, by 1971, we were able to interest Merck, which had considerable experience with vaccines."

Blood-derived vaccine

During the next few years, a series of human and primate observations by scientists including Maurice Hilleman (who was responsible for vaccines at Merck), S. Krugman, R. Purcell, P. Maupas, and others provided additional support for the vaccine. In 1980, the results of the first field trial were published by W. Szmuness and his colleagues in New York City."

The American microbiologist/vaccinologist Maurice Hilleman at Merck used three treatments (pepsin, urea and formaldehyde) of blood serum together with rigorous filtration to yield a product that could be used as a safe vaccine. Hilleman hypothesized that he could make an HBV vaccine by injecting patients with hepatitis B surface protein. In theory, this would be very safe, as these excess surface proteins lacked infectious viral DNA. The immune system, recognizing the surface proteins as foreign, would manufacture specially shaped antibodies, custom-made to bind to, and destroy, these proteins. Then, in the future, if the patient were infected with HBV, the immune system could promptly deploy protective antibodies, destroying the viruses before they could do any harm. [61]

Hilleman collected blood from gay men and intravenous drug users—groups known to be at risk for viral hepatitis. This was in the late 1970s, when HIV was yet unknown to medicine. In addition to the sought-after hepatitis B surface proteins, the blood samples likely contained HIV. Hilleman devised a multistep process to purify this blood so that only the hepatitis B surface proteins remained. Every known virus was killed by this process, and Hilleman was confident that the vaccine was safe. [61]

The first large-scale trials for the blood-derived vaccine were performed on gay men, in accordance with their high-risk status. Later, Hilleman's vaccine was falsely blamed for igniting the AIDS epidemic. (See Wolf Szmuness) But, although the purified blood vaccine seemed questionable, it was determined to have indeed been free of HIV. The purification process had destroyed all viruses—including HIV. [61] The vaccine was approved in 1981. [18]

Recombinant vaccine

The blood-derived hepatitis B vaccine was withdrawn from the marketplace in 1986, replaced by Maurice Hilleman's improved recombinant hepatitis B vaccine which was approved by the FDA on 23 July 1986. [18] [20] [62] It was the first human vaccine produced by recombinant DNA methods. [62] For this work, scientists at Merck & Co. collaborated with William J. Rutter and colleagues at the University of California at San Francisco, as well as Benjamin Hall and colleagues at the University of Washington. [63] In 1981, William J. Rutter, Pablo DT Valenzuela and Edward Penhoet (UC Berkeley) co-founded the Chiron Corporation in Emeryville, California, which collaborated with Merck. [63] [64]

The recombinant vaccine is based on Hepatitis B surface antigen (HBsAg) gene inserted into yeast ( Saccharomyces cerevisiae ) cells which are free of any concerns associated with human blood products. [18] [65] This allows the yeast to produce only the noninfectious surface protein, without any danger of introducing actual viral DNA into the final product. [61] The vaccine contains the adjuvant amorphous aluminum hydroxyphosphate sulfate. [65]

In 2017, a two-dose HBV vaccine for adults, Heplisav-B gained U.S. Food and Drug Administration (FDA) approval. [4] It uses recombinant HB surface antigen, similar to previous vaccines, but includes a novel CpG 1018 adjuvant, a 22-mer phosphorothioate-linked oligodeoxynucleotide. It was non-inferior with respect to immunogenicity. [66]

In November 2021, Hepatitis B Vaccine (Recombinant) (Prehevbrio) was approved by the FDA. [7] [67] [68] [69]

Immunization schedule

The US CDC ACIP first recommended the vaccine for all newborns in 1991. [70] Prior to this, the vaccine was only recommended for high-risk groups. As of the 1991 recommendation for universal newborn Hepatitis B vaccination, no other vaccines were routinely recommended for all newborns in the United States, and remains one of the very few vaccines routinely recommended for administration at birth.

Manufacture

The vaccine contains one of the viral envelope proteins, Hepatitis B surface antigen (HBsAg). It is produced by yeast cells, into which the gene for HBsAg has been inserted. [65] Afterward an immune system antibody to HBsAg is established in the bloodstream. The antibody is known as anti-HBs. This antibody and immune system memory then provide immunity to hepatitis B virus (HBV) infection. [71]

Society and culture

On 10 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Heplisav B, intended for the active immunization against hepatitis B virus infection (HBV). [72] The applicant for this medicinal product is Dynavax GmbH. [72] It was approved for medical use in the European Union in February 2021. [9]

On 24 February 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product PreHevbri, intended for the active immunization against hepatitis B virus infection (HBV). [73] The applicant for this medicinal product is VBI Vaccines B.V. [73] PreHevbri was approved for medical use in the European Union in April 2022. [10] [12]

Brand names

The common brands available are Recombivax HB (Merck), [5] Engerix-B (GSK), [6] Elovac B (Human Biologicals Institute, a division of Indian Immunologicals Limited), Genevac B (Serum Institute), Shanvac B, Heplisav-B, [4] [9] and Prehevbrio, [7]

Twinrix (GSK) is a vaccine against hepatitis A and hepatitis B. [74] [75]

Pediarix is a vaccine against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis. [76]

Vaxelis is a vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B (Meningococcal Protein Conjugate), and hepatitis B. [77] [78]

Fendrix (hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)) was approved for medical use in the European Union in 2005. [79]

Related Research Articles

<span class="mw-page-title-main">Vaccine</span> Pathogen-derived preparation that provides acquired immunity to an infectious disease

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and recognize further and destroy any of the microorganisms associated with that agent that it may encounter in the future.

<span class="mw-page-title-main">Hepatitis</span> Inflammation of the liver

Hepatitis is inflammation of the liver tissue. Some people or animals with hepatitis have no symptoms, whereas others develop yellow discoloration of the skin and whites of the eyes (jaundice), poor appetite, vomiting, tiredness, abdominal pain, and diarrhea. Hepatitis is acute if it resolves within six months, and chronic if it lasts longer than six months. Acute hepatitis can resolve on its own, progress to chronic hepatitis, or (rarely) result in acute liver failure. Chronic hepatitis may progress to scarring of the liver (cirrhosis), liver failure, and liver cancer.

<span class="mw-page-title-main">Seroconversion</span> Development of specific antibodies in the blood serum as a result of infection or immunization

In immunology, seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination. During infection or immunization, antigens enter the blood, and the immune system begins to produce antibodies in response. Before seroconversion, the antigen itself may or may not be detectable, but the antibody is absent. During seroconversion, the antibody is present but not yet detectable. After seroconversion, the antibody is detectable by standard techniques and remains detectable unless the individual seroreverts, in a phenomenon called seroreversion, or loss of antibody detectability, which can occur due to weakening of the immune system or decreasing antibody concentrations over time. Seroconversion refers the production of specific antibodies against specific antigens, meaning that a single infection could cause multiple waves of seroconversion against different antigens. Similarly, a single antigen could cause multiple waves of seroconversion with different classes of antibodies. For example, most antigens prompt seroconversion for the IgM class of antibodies first, and subsequently the IgG class.

<span class="mw-page-title-main">DPT vaccine</span> Combination vaccine

The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis, and tetanus (lockjaw). The vaccine components include diphtheria and tetanus toxoids, and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain any live pathogen, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest.

Post-exposure prophylaxis, also known as post-exposure prevention (PEP), is any preventive medical treatment started after exposure to a pathogen in order to prevent the infection from occurring.

<span class="mw-page-title-main">Influenza vaccine</span> Vaccine against influenza

Influenza vaccines, colloquially known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. Vaccination against influenza began in the 1930s, with large-scale availability in the United States beginning in 1945.

The MMRV vaccine combines the attenuated virus MMR vaccine with the addition of the varicella (chickenpox) vaccine. The MMRV vaccine is typically given to children between one and two years of age.

<span class="mw-page-title-main">Booster dose</span> Additional administration of vaccine

A booster dose is an extra administration of a vaccine after an earlier (primer) dose. After initial immunization, a booster provides a re-exposure to the immunizing antigen. It is intended to increase immunity against that antigen back to protective levels after memory against that antigen has declined through time. For example, tetanus shot boosters are often recommended every 10 years, by which point memory cells specific against tetanus lose their function or undergo apoptosis.

<span class="mw-page-title-main">Hepatitis A and B vaccine</span> Vaccine against hepatitis virus A and B

Combined hepatitis A and B vaccine, is used to provide protection against hepatitis A and hepatitis B. It is given by injection into muscle.

A breakthrough infection is a case of illness in which a vaccinated individual becomes infected with the illness, because the vaccine has failed to provide complete immunity against the pathogen. Breakthrough infections have been identified in individuals immunized against a variety of diseases including mumps, varicella (Chickenpox), influenza, and COVID-19. The characteristics of the breakthrough infection are dependent on the virus itself. Often, infection of the vaccinated individual results in milder symptoms and shorter duration than if the infection were contracted naturally.

<span class="mw-page-title-main">Zoster vaccine</span> Vaccine to prevent shingles

A zoster vaccine is a vaccine that reduces the incidence of herpes zoster (shingles), a disease caused by reactivation of the varicella zoster virus, which is also responsible for chickenpox. Shingles provokes a painful rash with blisters, and can be followed by chronic pain, as well as other complications. Older people are more often affected, as are people with weakened immune systems (immunosuppression). Both shingles and postherpetic neuralgia can be prevented by vaccination.

<span class="mw-page-title-main">Varicella vaccine</span> Vaccine to prevent chickenpox

Varicella vaccine, also known as chickenpox vaccine, is a vaccine that protects against chickenpox. One dose of vaccine prevents 95% of moderate disease and 100% of severe disease. Two doses of vaccine are more effective than one. If given to those who are not immune within five days of exposure to chickenpox it prevents most cases of disease. Vaccinating a large portion of the population also protects those who are not vaccinated. It is given by injection just under the skin. Another vaccine, known as zoster vaccine, is used to prevent diseases caused by the same virus – the varicella zoster virus.

<span class="mw-page-title-main">Hepatitis A vaccine</span> Vaccine to prevent hepatitis A

Hepatitis A vaccine is a vaccine that prevents hepatitis A. It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life. If given, two doses are recommended beginning after the age of one. It is given by injection into a muscle. The first hepatitis A vaccine was approved in Europe in 1991, and the United States in 1995. It is on the World Health Organization's List of Essential Medicines.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

<span class="mw-page-title-main">Hepatitis B</span> Human viral infection

Hepatitis B is an infectious disease caused by the Hepatitis B virus (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection.

<span class="mw-page-title-main">Measles vaccine</span> Vaccine used to prevent measles

Measles vaccine protects against becoming infected with measles. Nearly all of those who do not develop immunity after a single dose develop it after a second dose. When the rate of vaccination within a population is greater than 92%, outbreaks of measles typically no longer occur; however, they may occur again if the rate of vaccination decreases. The vaccine's effectiveness lasts many years. It is unclear if it becomes less effective over time. The vaccine may also protect against measles if given within a couple of days after exposure to measles.

<span class="mw-page-title-main">Yellow fever vaccine</span> Vaccine that protects against yellow fever

Yellow fever vaccine is a vaccine that protects against yellow fever. Yellow fever is a viral infection that occurs in Africa and South America. Most people begin to develop immunity within ten days of vaccination and 99% are protected within one month, and this appears to be lifelong. The vaccine can be used to control outbreaks of disease. It is given either by injection into a muscle or just under the skin.

A subunit vaccine is a vaccine that contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response. Subunit vaccine can be made from dissembled viral particles in cell culture or recombinant DNA expression, in which case it is a recombinant subunit vaccine.

<span class="mw-page-title-main">Tetanus vaccine</span> Vaccines used to prevent tetanus

Tetanus vaccine, also known as tetanus toxoid (TT), is a toxoid vaccine used to prevent tetanus. During childhood, five doses are recommended, with a sixth given during adolescence.

DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP-IPV-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B.

References

  1. "Hepatitis b adult vaccine Pregnancy and Breastfeeding Warnings". Drugs.com. 27 April 2020. Archived from the original on 27 October 2020. Retrieved 19 December 2021.
  2. "Engerix B SmPC". Datapharm. 24 April 2017. Archived from the original on 22 September 2019. Retrieved 22 September 2019.
  3. "HBVaxPro SmPC". Datapharm. 12 March 2019. Archived from the original on 22 September 2019. Retrieved 22 September 2019.
  4. 1 2 3 "Heplisav-B". U.S. Food and Drug Administration (FDA). Archived from the original on 22 September 2019. Retrieved 22 September 2019.
  5. 1 2 "Recombivax HB". U.S. Food and Drug Administration (FDA). 24 April 2019. Archived from the original on 11 February 2020. Retrieved 6 May 2020.
  6. 1 2 "Engerix-B". U.S. Food and Drug Administration (FDA). 3 October 2019. Archived from the original on 11 February 2020. Retrieved 6 May 2020.
  7. 1 2 3 "PreHevbrio". U.S. Food and Drug Administration. 13 December 2021. Archived from the original on 19 December 2021. Retrieved 19 December 2021.
  8. "Hepatitis B Vaccine Monograph for Professionals". Drugs.com. 1 September 2019. Archived from the original on 21 October 2019. Retrieved 19 December 2019.
  9. 1 2 3 "Heplisav B EPAR". European Medicines Agency (EMA). 9 December 2020. Archived from the original on 8 March 2021. Retrieved 1 March 2021.
  10. 1 2 "PreHevbri EPAR". European Medicines Agency (EMA). 22 February 2022. Retrieved 3 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. "Heplisav B Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  12. 1 2 "PreHevbri Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  13. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 World Health Organization (July 2017). "Hepatitis B vaccines: WHO position paper – July 2017" (PDF). Wkly. Epidemiol. Rec. 92 (27): 369–92. hdl: 10665/255873 . PMID   28685564.
  14. 1 2 Chen W, Gluud C (October 2005). "Vaccines for preventing hepatitis B in health-care workers". The Cochrane Database of Systematic Reviews (4): CD000100. doi:10.1002/14651858.CD000100.pub3. PMID   16235273.
  15. Moticka E (25 November 2015). A Historical Perspective on Evidence-Based Immunology. Newnes. p. 336. ISBN   9780123983756.
  16. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl: 10665/325771 . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  17. World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl: 10665/345533 . WHO/MHP/HPS/EML/2021.02.
  18. 1 2 3 4 Tulchinsky TH (2018). "Maurice Hilleman: Creator of Vaccines That Changed the World". Case Studies in Public Health: 443–470. doi:10.1016/B978-0-12-804571-8.00003-2. ISBN   9780128045718. PMC   7150172 .
  19. Oransky I (14 May 2005). "Maurice R. Hilleman". Lancet. 365 (9472): 1682. doi:10.1016/S0140-6736(05)66536-1. PMID   15912596. S2CID   46630955.
  20. 1 2 Offit PA (2007). "Chapter 8: Blood". Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases (PDF). HarperCollins. pp. 115–126, 136–140. Archived (PDF) from the original on 5 October 2021. Retrieved 9 January 2021.
  21. Committee on Infectious Diseases; Committee On Fetus And Newborn (September 2017). "Elimination of Perinatal Hepatitis B: Providing the First Vaccine Dose Within 24 Hours of Birth". Pediatrics. 140 (3): e20171870. doi: 10.1542/peds.2017-1870 . PMID   28847980.
  22. Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Shau WY, Chen DS (June 1997). "Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group". The New England Journal of Medicine. 336 (26): 1855–9. doi: 10.1056/NEJM199706263362602 . PMID   9197213.
  23. "Hepatitis B vaccine". Nhs.uk. Archived from the original on 28 June 2017. Retrieved 27 April 2017.
  24. Joint Committee on Vaccination and Immunisation (2006). "Chapter 12 Immunisation of healthcare and laboratory staff—Hepatitis B". Immunisation Against Infectious Disease 2006 ("The Green Book") (3rd ed.). Edinburgh: Stationery Office. p. 468. ISBN   978-0-11-322528-6. Archived from the original (PDF) on 7 January 2013. Retrieved 25 March 2008.
  25. U.S. Centers for Disease Control and Prevention (CDC) (December 2011). "Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR Morb. Mortal. Wkly. Rep. 60 (50): 1709–11. PMID   22189894. Archived (PDF) from the original on 17 October 2020. Retrieved 7 May 2020.
  26. Bar-On ES, Goldberg E, Hellmann S, Leibovici L (April 2012). "Combined DTP–HBV–HIB vaccine versus separately administered DTP–HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB)". The Cochrane Database of Systematic Reviews. 4 (4): CD005530. doi:10.1002/14651858.CD005530.pub3. PMID   22513932.
  27. U.S. Centers for Disease Control and Prevention (CDC) (March 2003). "FDA licensure of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant), and poliovirus vaccine combined, (PEDIARIX) for use in infants". MMWR Morb. Mortal. Wkly. Rep. 52 (10): 203–4. PMID   12653460.
  28. U.S. Centers for Disease Control and Prevention (CDC) (October 2008). "Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine and guidance for use as a booster dose" (PDF). MMWR Morb. Mortal. Wkly. Rep. 57 (39): 1078–9. PMID   18830212. Archived (PDF) from the original on 7 May 2020. Retrieved 7 May 2020.
  29. Schillie S, Vellozzi C, Reingold A, Harris A, Haber P, Ward JW, Nelson NP (January 2018). "Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices" (PDF). MMWR Recomm Rep. 67 (1): 1–31. doi:10.15585/mmwr.rr6701a1. PMC   5837403 . PMID   29939980. Archived (PDF) from the original on 3 July 2020. Retrieved 7 May 2020.
  30. 1 2 Lee C, Gong Y, Brok J, Boxall EH, Gluud C (April 2006). "Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers". The Cochrane Database of Systematic Reviews (2): CD004790. doi:10.1002/14651858.CD004790.pub2. PMID   16625613.
  31. Sangkomkamhang US, Lumbiganon P, Laopaiboon M (November 2014). "Hepatitis B vaccination during pregnancy for preventing infant infection". The Cochrane Database of Systematic Reviews. 2014 (11): CD007879. doi:10.1002/14651858.CD007879.pub3. PMC   7185858 . PMID   25385500.
  32. Eke AC, Eleje GU, Eke UA, Xia Y, Liu J (February 2017). "Hepatitis B immunoglobulin during pregnancy for prevention of mother-to-child transmission of hepatitis B virus". The Cochrane Database of Systematic Reviews. 2017 (2): CD008545. doi:10.1002/14651858.CD008545.pub2. PMC   6464495 . PMID   28188612.
  33. 1 2 "Ask the Experts: Hepatitis B". Immunize.org. Immunization Action Coalition. 26 May 2022. Archived from the original on 16 October 2022. Retrieved 25 September 2022.
  34. 1 2 3 4 5 Joint Committee on Vaccination and Immunisation (2006). "Chapter 18: Hepatitis B". Immunisation Against Infectious Disease 2006 ("The Green Book") (3rd edition (Chapter 18 revised 10 October 2007) ed.). Edinburgh: Stationery Office. p. 468. ISBN   978-0-11-322528-6. Archived from the original (PDF) on 7 January 2013.
  35. 1 2 Filippelli M, Lionetti E, Gennaro A, Lanzafame A, Arrigo T, Salpietro C, La Rosa M, Leonardi S (August 2014). "Hepatitis B vaccine by intradermal route in non responder patients: an update". World J. Gastroenterol. (Review). 20 (30): 10383–94. doi: 10.3748/wjg.v20.i30.10383 . PMC   4130845 . PMID   25132754.
  36. Levitz RE, Cooper BW, Regan HC (February 1995). "Immunization with high-dose intradermal recombinant hepatitis B vaccine in healthcare workers who failed to respond to intramuscular vaccination". Infection Control and Hospital Epidemiology. 16 (2): 88–91. doi:10.1086/647062. PMID   7759824.
  37. Cardell K, Akerlind B, Sällberg M, Frydén A (August 2008). "Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine". The Journal of Infectious Diseases. 198 (3): 299–304. doi: 10.1086/589722 . PMID   18544037.
  38. Roome AJ, Walsh SJ, Cartter ML, Hadler JL (1993). "Hepatitis B vaccine responsiveness in Connecticut public safety personnel". JAMA. 270 (24): 2931–4. doi:10.1001/jama.270.24.2931. PMID   8254852.
  39. Rosman AS, Basu P, Galvin K, Lieber CS (September 1997). "Efficacy of a high and accelerated dose of hepatitis B vaccine in alcoholic patients: a randomized clinical trial". The American Journal of Medicine. 103 (3): 217–22. doi:10.1016/S0002-9343(97)00132-0. PMID   9316554.
  40. Pasricha N, Datta U, Chawla Y, Singh S, Arora SK, Sud A, Minz RW, Saikia B, Singh H, James I, Sehgal S (March 2006). "Immune responses in patients with HIV infection after vaccination with recombinant Hepatitis B virus vaccine". BMC Infectious Diseases. 6: 65. doi: 10.1186/1471-2334-6-65 . PMC   1525180 . PMID   16571140. Cold or Flu like symptoms can develop after receiving the vaccine, but these are short lived. As with any injection, the muscle can become tender around the injection point for some time afterwards
  41. Krugman S, Davidson M (1987). "Hepatitis B vaccine: prospects for duration of immunity". The Yale Journal of Biology and Medicine. 60 (4): 333–9. PMC   2590237 . PMID   3660859.
  42. Petersen KM, Bulkow LR, McMahon BJ, Zanis C, Getty M, Peters H, Parkinson AJ (July 2004). "Duration of hepatitis B immunity in low risk children receiving hepatitis B vaccinations from birth" (Free full text). The Pediatric Infectious Disease Journal. 23 (7): 650–5. doi:10.1097/01.inf.0000130952.96259.fd. PMID   15247604. S2CID   10541868. Archived from the original on 5 June 2015.
  43. Van Damme P, Van Herck K (March 2007). "A review of the long-term protection after hepatitis A and B vaccination". Travel Medicine and Infectious Disease. 5 (2): 79–84. doi:10.1016/j.tmaid.2006.04.004. PMID   17298912.
  44. Van Damme, Pierre (1 July 2016). "Long-term Protection After Hepatitis B Vaccine". Journal of Infectious Diseases. 214 (1): 1–3. doi: 10.1093/infdis/jiv750 . PMID   26802140.
  45. Gabbuti A, Romanò L, Blanc P, Meacci F, Amendola A, Mele A, Mazzotta F, Zanetti AR (April 2007). "Long-term immunogenicity of hepatitis B vaccination in a cohort of Italian healthy adolescents". Vaccine. 25 (16): 3129–32. doi:10.1016/j.vaccine.2007.01.045. PMID   17291637.
  46. "Are booster immunisations needed for lifelong hepatitis B immunity? European Consensus Group on Hepatitis B Immunity". Lancet. 355 (9203): 561–5. February 2000. doi:10.1016/S0140-6736(99)07239-6. PMID   10683019. S2CID   32401362.
  47. Borgia G, Carleo MA, Gaeta GB, Gentile I (September 2012). "Hepatitis B in pregnancy". World Journal of Gastroenterology. 18 (34): 4677–83. doi: 10.3748/wjg.v18.i34.4677 . PMC   3442205 . PMID   23002336.
  48. 1 2 Martínez-Sernández V, Figueiras A (August 2013). "Central nervous system demyelinating diseases and recombinant hepatitis B vaccination: a critical systematic review of scientific production". Journal of Neurology. 260 (8): 1951–9. doi: 10.1007/s00415-012-6716-y . PMID   23086181. S2CID   20362426.
  49. "FAQs about Hepatitis B Vaccine (Hep B) and Multiple Sclerosis". U.S. Centers for Disease Control and Prevention (CDC). 9 October 2009. Archived from the original on 10 November 2009.
  50. Mouchet J, Salvo F, Raschi E, Poluzzi E, Antonazzo IC, De Ponti F, Bégaud B (March 2018). "Hepatitis B vaccination and the putative risk of central demyelinating diseases - A systematic review and meta-analysis". Vaccine. 36 (12): 1548–55. doi:10.1016/j.vaccine.2018.02.036. PMID   29454521.
  51. Hernán MA, Jick SS, Olek MJ, Jick H (September 2004). "Recombinant hepatitis B vaccine and the risk of multiple sclerosis: a prospective study". Neurology. 63 (5): 838–42. doi:10.1212/01.WNL.0000138433.61870.82. PMID   15365133. S2CID   25309517.
  52. Zuckerman JN (February 2006). "Protective efficacy, immunotherapeutic potential, and safety of hepatitis B vaccines". Journal of Medical Virology. 78 (2): 169–77. doi:10.1002/jmv.20524. PMID   16372285. S2CID   45526262.
  53. Mikaeloff Y, Caridade G, Rossier M, Suissa S, Tardieu M (December 2007). "Hepatitis B vaccination and the risk of childhood-onset multiple sclerosis". Archives of Pediatrics & Adolescent Medicine. 161 (12): 1176–82. doi: 10.1001/archpedi.161.12.1176 . PMID   18056563.
  54. Elwood JM, Ameratunga R (September 2018). "Autoimmune diseases after hepatitis B immunization in adults: Literature review and meta-analysis, with reference to 'autoimmune/autoinflammatory syndrome induced by adjuvants' (ASIA)". Vaccine (Review). 36 (38): 5796–5802. doi:10.1016/j.vaccine.2018.07.074. PMID   30100071. S2CID   51967163.
  55. "Share of one-year-olds vaccinated against hepatitis B". Our World in Data. Archived from the original on 21 April 2020. Retrieved 22 April 2020.
  56. "Hepatitis B (HepB3) Immunization coverage estimates by country". WHO. Archived from the original on 11 May 2016. Retrieved 8 June 2016.
  57. Blumberg BS, Alter HJ, Visnich S (February 1965). "A "New" Antigen In Leukemia Sera". JAMA. 191 (7): 541–6. doi:10.1001/jama.1965.03080070025007. PMID   14239025.
  58. Howard, Colin; Zuckerman, Arie J. (1979). Hepatitis viruses of man. Boston: Academic Press. pp.  16–18. ISBN   978-0-12-782150-4.
  59. "The Nobel Prize in Physiology or Medicine 1976". NobelPrize.org. Archived from the original on 23 May 2020. Retrieved 14 February 2021.
  60. Blumberg, Baruch (2002), Hepatitis B: The Hunt for a Killer Virus, Princeton: Princeton University Press.
  61. 1 2 3 4 "World Hepatitis Day: The History of the Hepatitis B Vaccine | Planned Parenthood Advocates of Arizona". Blog.advocatesaz.org. 26 July 2012. Archived from the original on 5 April 2016. Retrieved 27 April 2017.
  62. 1 2 "Vaccine Development & Licensing Events". History of Vaccines. Archived from the original on 16 April 2022. Retrieved 14 February 2021.
  63. 1 2 "THE HEPATITIS B STORY" (PDF). National Academy of Sciences . February 2000. Archived (PDF) from the original on 28 July 2021.
  64. Fisher LM (13 October 1986). "Biotechnology Spotlight Now Shines on Chiron". The New York Times. ISSN   0362-4331. Archived from the original on 26 August 2017. Retrieved 14 February 2021.
  65. 1 2 3 "Hepatitis B Vaccine from Merck". Archived from the original on 21 April 2010. Retrieved 9 May 2010.
  66. Dynavax Technologies Corp. "Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] label" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 25 April 2018. Retrieved 27 November 2018.
  67. "ACIP Evidence to Recommendations for use of PreHevbrio Hepatitis B (HepB) Vaccine in Adults". U.S. Centers for Disease Control and Prevention (CDC). 31 March 2022. Archived from the original on 18 August 2022. Retrieved 15 February 2023.
  68. "Grading of Recommendations Assessment, Development and Evaluation (GRADE): PreHevbrio for Adults". U.S. Centers for Disease Control and Prevention (CDC). 31 March 2022. Archived from the original on 3 December 2022. Retrieved 15 February 2023.
  69. Murthy N, Wodi AP, McNally V, Cineas S, Ault K (February 2023). "Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2023" (PDF). MMWR. Morbidity and Mortality Weekly Report. 72 (6): 141–144. doi:10.15585/mmwr.mm7206a2. PMC   9925137 . PMID   36757861. Archived (PDF) from the original on 9 February 2023. Retrieved 16 February 2023.
  70. "Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee". MMWR . 40 (RR-13): 1–19. 22 November 1991. PMID   1835756 . Retrieved 15 May 2023.
  71. "CDC Viral Hepatitis". U.S. Centers for Disease Control and Prevention (CDC). 24 July 2009. Archived from the original on 20 October 2009. Retrieved 22 October 2009.
  72. 1 2 "Heplisav B: Pending EC decision". European Medicines Agency (EMA). 10 December 2020. Archived from the original on 11 December 2020. Retrieved 11 December 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  73. 1 2 "PreHevbri: Pending EC decision". European Medicines Agency (EMA). 25 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  74. "Hepatitis A & hepatitis B recombinant vaccine - Drug Summary". www.pdr.net. Prescriber's Digital Reference. Archived from the original on 4 June 2019. Retrieved 4 June 2019.
  75. "Twinrix". U.S. Food and Drug Administration (FDA). Archived from the original on 22 September 2019. Retrieved 22 September 2019.
  76. "Pediarix". U.S. Food and Drug Administration (FDA). Archived from the original on 22 September 2019. Retrieved 22 September 2019.
  77. "Vaxelis EPAR". European Medicines Agency (EMA). 19 February 2019. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  78. "Vaxelis". U.S. Food and Drug Administration (FDA). STN 125563. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  79. "Fendrix EPAR". European Medicines Agency (EMA). 2 February 2005. Retrieved 27 December 2023.

Further reading